ECHOSCAN

GUDID 04987669100448

Ultrasonic waves are the sound waves pitched above the range of human hearing whose frequency is 20,000 Hz or more. In the medical field, ultrasonic w

NIDEK CO.,LTD.

Ultrasound pachymeter
Primary Device ID04987669100448
NIH Device Record Keyc6121091-b3a5-4f71-ba84-5c269bd49bbc
Commercial Distribution StatusIn Commercial Distribution
Brand NameECHOSCAN
Version Model NumberUS-4000
Company DUNS690635461
Company NameNIDEK CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-223-9044
Emailinfo@nidek.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104987669100448 [Primary]

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-04-25
Device Publish Date2016-08-27

On-Brand Devices [ECHOSCAN]

04987669100455The NIDEK US-500 Echoscan is an ultrasonic device to measure the axial length and corneal thickn
04987669100448Ultrasonic waves are the sound waves pitched above the range of human hearing whose frequency is

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